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Complete edentulism Areas of application: Denture bases in removable complete denture prosthetics

Ivotion® Base Print is a light-curing resin material for stereolithography 3D printing. It is suitable for the fabrication of permanent denture bases in removable complete denture prosthetics. The material can be processed with approved 3D printing system. The dental professional starts with preparation of the printing procedure, cleaning, post-curing, finishing and polishing. A denture fabricated with Ivotion Base Print can be repaired and relined using a conventional self-curing denture base material.

The provided text is a 510(k) summary for the medical device "Ivotion Base Print." It describes the device, its intended use, and its comparison to a predicate device to establish substantial equivalence.

Based on the information provided, this document does not describe a study involving an AI/ML powered device and therefore does not contain the requested information regarding acceptance criteria, study design for AI/ML performance, ground truth establishment, or human-in-the-loop studies.

The device "Ivotion Base Print" is a light-curing resin material for stereolithography 3D printing. The studies mentioned are primarily non-clinical performance testing to assess physical properties and biocompatibility testing according to ISO standards, which are standard for dental materials, not AI/ML algorithms.

Therefore, I cannot extract the information requested in your prompt because the provided text is not about an AI/ML powered medical device and the associated performance studies you are asking for.

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